SOP of Disintegration test apparatus
When we take a tablet as medicine it looks quite good in shape and shining colors but whether it will affect good or not depends on its disintegration properties. Disintegration means releasing drug content in the body on oral consumption. A disintegration test is usually done for checking the tablet or capsule's disintegration properties. To carry out this test disintegration test apparatus is used. This is a simple mechanical apparatus where two baskets move vertically in a water-filled vessel. The tablet in testing is kept in the cavities of the basket. The motive of this test is to know the dissolving ability of the tablet or capsule intended to use. If a tablet failed to this test that will not able to release its whole drug content in the stomach which will lead it to substandard medicine. The test is carried out as per individual monograph or according to the SOP of Disintegration test apparatus.
SOP for Operation and Calibration of Disintegration test apparatus
1. Objective: To lay down a procedure for the Calibration of Disintegration test apparatus.
2. Scope: The procedure of this SOP shall be applicable to the Q.C. Department of XYZ Pharma company
3. Responsibility : Quality Control Chemist
4. Accountability : Quality Control Manager
5. Abbreviations :
S.O.P. : Standard Operating Procedure
QC : Quality Control
QA : Quality Assurance
6. Procedure : Operation
a) Ensure that clean purified water is filled in glass beakers at desired level.of DT machine
b)Switch on the main supply on the instrument ON/OFF switch.
c) Switch On the heater by pressing the “Temp” key on the panel.
d) Press “Set” & Temp” key to set the temperature to 37oC.
e) Press “Set” & Timer” key to set the desired test time.
f) Place one tablet/Capsule to be tested in each of the six cylinders of basket rack assembly.
g) Press “Start/Stop” key once to start the test.
h) Watch the complete disintegration of tablet/capsule and note down the time.
i) Press” Star/Stop” key to stop the test.
Calibration of Disintegration test apparatus
6 Calibration of Glass Tubes:
Length: 77.5 + 2.5mm
Internal Diameter: 21.5mm
Wall Thickness: 2mm
6.2 Calibration of Gauze: Woven gauze made of S.S. wire of 635micron in diameter with nominal mesh apertures of 2.0mm, (8No. Sieve).
6.3 Calibration of Disc.
Diameter: 20.7 + 0.15mm
Thickness: 9.5 + 0.15mm
Relative Density: 1.18 to 1.20
6.4. Calibration of Cycle: 28 to 32 cycles per minute
6.5. Calibration on Temp. : Temp of liquid should be maintained at 37oC + 2oC & calibrate with a thermometer.
6.6. Calibration of Time: With the help of stopwatch.
Frequency of Calibration : Once in a month
Recommended Distribution:
S.N Department Distribution 1 Quality control Yes2 table
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